Phase I/IIa Study of BR790 in Combination With Tislelizumab in Adult Subjects With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-10

Study Completion Date

2024-12-31

Brief Summary

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This study is a Phase I/IIa, multi-center, open-label study of BR790 in combination with Tislelizumab with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors.

These treatment to characterize the safety, tolerability, PK, PD and preliminary antitumor activity.

The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

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Detailed Description

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Phase 1 (Dose Escalation Phase of BR790 Tablets Combined with Tislelizumab Injection): According to the incidence of DLT in BR790 Tablets Combined with Tislelizumab Injection Monoclonal Antibody in the Treatment of Advanced Solid Tumors, MTD and the Phase 2 clinical trial dose (RP2D) combining PK , efficacy and safety data were determined.

Stage II (BR790 Tablets combined with tislelizumab injection dose expansion stage): Evaluate the objective response rate (ORR) of BR790 Tablets combined with tislelizumab injection according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 .

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BR790+Tislelizumab dose escalation

Dose escalation part

Group Type EXPERIMENTAL

BR790+Tislelizumab

Intervention Type DRUG

BR790 will be administered orally, variable dose.

Tislelizumab will be administered as an intravenous infusion,fixed dose.

BR790+Tislelizumab dose expansion

Dose expansion part

Group Type EXPERIMENTAL

BR790+Tislelizumab

Intervention Type DRUG

BR790 will be administered orally, variable dose.

Tislelizumab will be administered as an intravenous infusion,fixed dose.

Interventions

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BR790+Tislelizumab

BR790 will be administered orally, variable dose.

Tislelizumab will be administered as an intravenous infusion,fixed dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Sign informed consent voluntarily.
2. Age ≥18 and ≤75 years old.
3. Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment.
4. Had at least one measurable lesion.
5. ECOG≤1.
6. Expected survival period ≥ 3 months.

Exclusion Criteria

1. Any previous treatment with SHP-2 inhibitor.
2. Symptomatic brain metastases.
3. Subjects with thoracic/ascites fluid that need drainage or intervention.
4. Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<90g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases), Cr \>1.5×ULN.
5. With uncontrolled severe disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No